NDC 0169-1833

Novolin R

Human Insulin

Novolin R is a Subcutaneous Injection, Solution in the Human Otc Drug category. It is labeled and distributed by Novo Nordisk. The primary component is Insulin Human.

Product ID0169-1833_46700b71-3f26-4aaa-8eb7-6ceeeb515c79
NDC0169-1833
Product TypeHuman Otc Drug
Proprietary NameNovolin R
Generic NameHuman Insulin
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1991-06-25
Marketing CategoryBLA / NDA
Application NumberBLA019938
Labeler NameNovo Nordisk
Substance NameINSULIN HUMAN
Active Ingredient Strength100 [iU]/mL
Pharm ClassesInsulin [CS], Insulin [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0169-1833-02

1 VIAL in 1 CARTON (0169-1833-02) > 10 mL in 1 VIAL
Marketing Start Date1991-06-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0169-1833-11 [00169183311]

Novolin R INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019938
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1991-06-25

NDC 0169-1833-02 [00169183302]

Novolin R INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019938
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1991-06-25

Drug Details

Active Ingredients

IngredientStrength
INSULIN HUMAN100 [iU]/mL

OpenFDA Data

SPL SET ID:aee7f1f3-612c-4027-8ce9-4fd1f41eed71
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311033
  • 311034
  • UPC Code
  • 0301691833022
  • 0301691833114
  • NDC Crossover Matching brand name "Novolin R" or generic name "Human Insulin"

    NDCBrand NameGeneric Name
    0169-1833NovolinHuman Insulin
    0169-1834NovolinHuman Insulin
    0169-1837NovolinHuman Insulin
    0169-3003NovolinHuman Insulin
    0169-3004NovolinHuman Insulin
    0169-3007NovolinHuman Insulin
    50090-0403NovolinHuman Insulin
    50090-0497NovolinHuman Insulin
    50090-0498NovolinHuman Insulin
    64725-1833NovolinHuman Insulin
    64725-1834NovolinHuman Insulin
    64725-1837NovolinHuman Insulin
    68071-1701NovolinHuman Insulin

    Trademark Results [Novolin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NOVOLIN
    NOVOLIN
    73498651 1384926 Live/Registered
    NOVO INDUSTRI A/S
    1984-09-10

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